Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K030549 |
Device Name |
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG |
Applicant |
GUIDCORP |
26531 YNEZ RD. |
TEMECULA,
CA
92591
|
|
Applicant Contact |
STACEY BROWN |
Correspondent |
GUIDCORP |
26531 YNEZ RD. |
TEMECULA,
CA
92591
|
|
Correspondent Contact |
STACEY BROWN |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 02/21/2003 |
Decision Date | 05/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|